July 11, 2011 - Although there has been the occasional regulatory setback for the makers of prescription skincare products that contain Hydroquinone (HQ) in the United States and Europe over the last several years, news shared in the latest earnings announcement from Obagi Medical Products still came as a surprise to many US physicians and patients across the country.

In their Q1 earnings call and related quarterly report released on May 5, 2011, Obagi’s CEO Al Hummel announced that Texas authorities have been going after doctors’ offices in the state, confiscating Obagi product containing Hydroquinone; which presumably would include their Nu-Derm®, Obagi-C® Rx, and ELASTIderm® brands, and citing the doctors for dispensing drugs without a pharmaceutical license.

Mr. Hummel also said that the Texas Attorney General’s office has informed Obagi that selling Hydroquinone through physician and medi-spa offices is against the Texas Food Drug and Cosmetic Act and the Texas Deceptive Trade Practices Act, and at least as far as Texas is concerned, Hydroquinone is an “unapproved drug”. The company also disclosed that Texas regulatory authorities first contacted them in 2009, and these recent actions appear to be a culmination of their tussle with the agency over the last several months.

The Texas actions don’t specifically indicate that the regulators have an issue with the safety of Hydroquinone administered under a physician’s care. The issue is presented more as an enforcement against the sale of the product outside of a licensed pharmacy. In fact, in early 2012, Obagi Medical Products, announced that they had come to a resolution with the state of Texas, and would “slowly” start selling in the stat again. However, these events are a concern for physicians, as they are the target of investigative office “visits”, product confiscations and agency citations – though it is not clear what the nature of those citations are, as of yet. Their distress is completely understandable, especially as one looks at the larger trend over the last three years that goes beyond state legislative activities:

*August2006: The FDA issued a new proposed ruling that would ban HQ and any product with “skin bleaching” claims from all cosmetics (currently HQ is allowed in the US at 2% or less concentrations), and require a new drug application process to be completed for all others to show safety and efficacy – they particularly questioned the safety of the product. This ruling would have mirrored similar regulations in Europe where HQ is banned in cosmetics. The FDA has not implemented this proposed ruling, stating that they would sponsor further safety studies before making a final decision.

*August 2009: The FDA issued a warning letter to the CEO of Galderma on improper labeling and promotion of Tri-Luma®, an FDA approved product for the treatment of melasma which combines 4% HQ with retinoids and a topical steroid. In part, the warning letter states that, “This unapproved [product material] includes several false and misleading claims about the product, including claims that suggest unapproved new uses and overstate the effectiveness of Tri-Luma, and it omits risk information and minimizes the risks of using Tri-Luma.”

In other words, Tri-Luma is approved as an effective treatment for Melasma over a few weeks or months under a physician’s care, but over time it has been treated too much like an ongoing daily skin-care regimen by patients who are looking for long-term solutions to their hyperpigmentation. In fact, the FDA was very clear in their letter, stating that Tri-Luma “is NOT [approved] for the maintenance treatment of melasma”, noting that it should be for short-term use, and patients need to be more informed about safety concerns and the potential for long-term damage to the skin if used for extended periods of time.

*August 2010: Doctors were largely surprised to wake up one day and find that Galderma issued a manufacturer’s recall of all Tri-luma product in the US and certain other countries. The reason given on totalrecallinfo.com was that it was due to a “manufacturer notice of sub-standard ingredient”. While this is an unusual occurrence for this type of topical prescription, it is not unheard of, and so many physicians expected it to be a temporary disruption; however, in the 8 months since, the makers have not resumed production and sale in the United States, and they have made no statement regarding when they will.

*October 2010: The Journal “Dermatologic Clinics“ released a new report entitled “Widespread Use of Toxic Skin Lightening Compounds: Medical and Psychosocial Aspects“. The report was authored by four prominent US physicians and cited a variety of evidences associating the use of HQ with many types of skin disorders, including a permanent darkening of the skin, known as ochronosis. The report dispelled the notion that these risks were found only with high HQ concentrations over 4%, citing cases related to concentrations as low as 3.5%. The report also noted that “contact dermatitis”, generally a temporary though undesirable side effect, occurs in about 70% of the patients who use HQ.

*April and July 2011: According to court documents, two separate and apparently unrelated lawsuits have been filed against sellers of Hydroquinone products. The first was filed in the Superior Court of the State of California in April, in San Francisco county by a woman who is suing Rodan and Fields, LLC., the company founded by dermatologists of the same name who have garnered great success with the Proactiv® line for acne. They also happen to be makers of a 2% hydroquinone product under the Rodan & Fields “Reverse” brand. According to the claim, this woman has developed irreversible skin discoloration and permanent disfigurement to the skin on her face, alleging that it comes from the use of Dr. Fields and Dr. Rodan’s HQ product.

The suit also claims that she was never properly informed of the risks associated with Hydroquinone, or that there are other safer alternatives commercially available, and that the defendant “knew or should have known” about these risks in supplying the product. This is a very new case, and so the merits and outcome are not known. It may be the first case of its kind in the United States, citing documented safety concerns with HQ as part of a foundation for claims related to using HQ products.

The second lawsuit was filed at the beginning of July in Hackensack, New Jersey, by a man named Deloy Southwell, who claims that he has leukemia from from the use of skin-care products containing 2% hydroquinone. The suit is against E. T. Browne Co., makers of Palmer’s Skin Success Eventone Fade Cream, which according to their website is not sold under a doctors care, but in mass market chains like Walmart, Target, KMart and drug stores chains such as Walgreens and CVS. As with the first lawsuit, the merits of the case, if any, are not yet clear. The suit claims that there is information on Hydroquinone suggesting that it can break down into more toxic substances in the skin that are leukemogenic. The common thread between both suits, however, is the assertion that the defendents “knowingly failed to provide needed, accurate and adequate information regarding the health hazards of the product,” and that Browne, “knew or should have known that applying Palmer’s Skin Success could cause serious injuries, including leukemia, in persons such as Mr. Southwell.”

These cases, whatever the merits may ultimately prove to be, are important for dispensing physicians and hydroquinone marketers alike to watch, as they may be a foreshadowing of things to come from more litigation down the road. Alternatively, it may help physicians, manufacturers, and retail outlets alike to consider ways to protect against these kinds of liabilities by ensuring that product users are informed of any potential risks and about the HQ alternatives that are now available.

This brings us back to today and the events taking place in Texas. The Obagi brand became the largest physician dispensed brand by selling HQ products. Now they appear to be joining doctors and patients across the country in looking for a better alternative for addressing skin hyperpigmentation.

Fortunately for patients, there are excellent new treatments and products that help address hyperpigmentation in skin. One such example is the SilkPeel® Dermalinfusion™, a device that combines microdermabrasion with the delivery of a skin brightening peptide manufactured under the “Lumixyl®” brand. Physicians around the country have been using this process very successfully.

“Until now we really haven’t had anything that works so effectively on hyperpigmentation and discolored skin,” said Dr. Ashish Bhatia in speaking of the Lumixyl SilkPeel procedure and a Lumixyl topical system used by the patient at home.

Lumixyl, discovered by Stanford researchers and dermatologists and made by Westlake Village, CA based Envy Medical, Inc., is one of the few non-toxic topical products that is approved as a cosmetic for ongoing use, giving it a huge advantage, as patients become more aware of the constraints in using HQ products on a temporary basis. The Lumixyl Topical Brightening System, just introduced in 2010 and already available in over 30 countries, appears to be hitting the market at just the right time.